Principal Regulatory Affairs Specialist
Palo Alto
Regulatory Affairs – Regulatory Affairs /
Full-time /
On-site
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.
The Principal Regulatory Affairs Specialist will be an individual contributor that will bring exceptional technical regulatory expertise. They will be part of a high-performing RA team and will be responsible for contributing to the development of regulatory strategies, preparing U.S. and major market submissions and obtaining approval for the ReCor Medical product portfolio.
Responsibilities and Duties
- Acts as technical regulatory lead on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA, EU and international product registrations and licensing requirements.
- Develops global regulatory strategies for new and modified products.
- Prepares and submits Pre-subs/ PMA/ IDE Submissions and supplements for new products and product changes as required to ensure timely approvals for clinical studies and market release.
- Provide support to currently marketed products as necessary including review of labeling, promotional material, product changes and documentation for changes.
- Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
- Complies with U.S. Food and Drug Administration (FDA), EU and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
- Keep abreast of changes in agency regulations and requirements, and trains stakeholders accordingly.
- Review and approve internal engineering documentation and change orders.
- Provide business and product information to international regulatory staff to enable development of strategies and requirements for global commercialization.
- Continuously evaluate, recommend, and implement improvements as needed.
- Provide mentorship within RA team.
- Willingness to perform other responsibilities as assigned.
Requirements
- Minimum of a Bachelors’ degree preferably in life sciences and/or biomedical engineering. Advanced degree preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Minimum of 10 years of regulatory experience within the medical device cardiovascular industry.
- PMA submission expertise is required
- Hardware and software regulatory experience is required.
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Extensive experience with formulating successful regulatory strategies that meet established approval timelines, while maintaining the highest level of quality.
- Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, US and major market regulatory requirements, project management, and negotiations.
- Experience with medical device hardware and software requirements and software regulations.
- Demonstrated ability to work well in dynamic and cross functional team environment.
- Demonstrated collaboration and leadership skills in team setting.
- Solid understanding of design control and change control.
- Experience reviewing design specifications and other technical documents, including software and capital equipment.
- Excellent interpersonal and communication skills, both oral and written.
- Ability to identify risk areas, make recommendations and escalate issues as appropriate.
- Self-motivated with excellent time management skills
- Strong team player and willing to work collaboratively.
$179,700 - $216,800 a year
(Commensurate with experience, skills, education and training)
COVID-19 vaccination requirements
At Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.
Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
